Ce marking requirements vary from directive to directive, and even within directives. In addition to the new approach ce marking directives, other european regulations may apply. Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. Ce marking for military aerospace and defence products. Complies with the applicable ehsrs of the 200642ec machinery directive and its amending directive we declare the technical file for this machine was compiled according to appendix vii part b and undertake to forward these to market monitoring authorities by request via our technical department. Products not covered under a new approach directive do not require ce marking. The individual directives have requirements on the ce mark. Complete list of all ce marking directives and guidelines to directives. Our machinery directive handbook facilitates the ce marking of industrial equipment by acting as a single point of reference for understanding and complying with the machinery directive. Some products are subject to several eu requirements at the same time. This makes the ce marking recognizable worldwide even to. The initials ce are in the standard, predefined form. For details, refer to ce conformite europeenne marking directive. Once my product has the ce mark is it good for life.
Each legislation directive or regulation has a scope, which describes in. European, ce marking regulations provide for a mechanism of market surveillance. The ce marking has a height of at least 5 millimetres. How do you know if your product requires marking and what directives do you need to mention in your ce. All ce marking directives require the manufacturer of the product to create a technical file which should contain the information required to show that the product properly complies with the requirements of the directives which apply to it. Rules governing the affixing of the ce marking should be laid down in this directive. Ce marking is currently required for many products sold in europe, yet many u. Other types of equipment that are within the scope of the machinery directive are. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. Do not accept client claims that you dont need to worry about the cemark. Pressure vessels over a certain volume are given a ce marking, and a declaration of conformity is provided. The ce marking shall be affixed to the pedelec visibly, legibly and indelibly in the immediate vicinity of the name of the manufacturer or his authorised representative.
Find out if your product requires ce marking and which directives apply to your product. Guidelines on ce marking 1 introduction it is an important goal of the european union to guarantee the free movement of goods within europe and to abolish technical barriers to trade. There are 25 product directives that require ce marking compliance activities and the affixing of the symbol. Whos going to enforce the requirements for ce marking. Ce marking a product is required if the product falls under one of the appropriate eu directives. It is illegal to place a ce mark on a product that is not covered by a directive. Ce marking pressure equipment 201468eu certification. The machinery directive 200642ec covers machinery that are match the definition provided in the directive. Ce marking generally requires a technical construction file, which forms the basis for the declaration of conformity. Best practices for rohs compliance in support of ce marking randy flinders greensoft technology, inc. Active implantable medical devices directive 90385eec.
The ce marking is also found on products sold outside the eea that have been manufactured to eea standards. The technical file is one of the corner stones of the ce marking process. It indicates to the appropriate bodies that the product may be legally offered for sale in their country. The ce marking is mandatory for equipment and protective systems that fall under the scope of the atex directive 114 201434eu. Ce marking is a part of the eus harmonisation legislation, which is mainly managed by directorategeneral for internal market, industry, entrepreneurship and smes. Several ce marking directives require that the technical file is written in an official language of the member state where the procedures are to be carried out, or in which the approved certification body socalled notified body is established, or in a. Our team of experts understand all these requirements and can help and advise you throughout every step of the process, from identifying appropriate directives, to correct application of the ce mark on your product. The technical file must contain all information that is necessary to demonstrate the conformity of the. Each legislation directive or regulation has a scope, which describes in detail the types of products to which it applies. The ecodesign directive for energyrelated products new ce marking directive taking the lead for erp intertek is the worlds leading erp authority providing easy and costefficient erp compliance evaluations and declarations for mandatory ce marking requirements.
Fees be aware that you may file only one application with one notified body. Whilst the ecodesign directive appears to have a rather broad application, unlike other directives that mandate ce marking which prescribe specific requirements and standards with which a given type of product must comply, the. Ce marking is compulsory for most products covered by the new approach directives. Understanding the machinery directive 2006 42ec the directive has been put in place because. By affixing the ce marking to a product, a manufacturer declares that the product meets all the legal requirements for ce marking and can be sold throughout the. The ec declaration of conformity and ce mark are valid as long as your product meets the applicable health, safety, and environmental requirements of the directive s. The social cost of the large number of accidents caused by the use of machinery can be reduced by.
Finally, the vehicle must have a ce conformity marking that consists of the initials ce as shown below. Ce marking and directive services marking of electrical equipment machinery, gas appliances and heating boilers within the european union electrical equipment, machinery, gas appliances and heating boilers to be marketed within the european economic area must bear the ce marking. Ensure that your product complies to these directives by testing or by asking your supplier the required documents to prove compliance. Complete list of all more than notified bodies for ce marking. Manufacturers in the european union eu and abroad must meet ce marking requirements where applicable in order to market their products in europe. You must make sure that your product complies with all the relevant requirements before affixing the ce marking to it. With reference to the pressure equipment directive 201468. This is a declaration by the manufacturer or by an importer located within the european economic area that the product complies with the essential health and safety requirements of the relevant eu directives. Instructions for affixing the ce marking on pressure equipment. When the ec directive takes effect, it will actually be impossible to export or sell the products covered by this directive in the eu area. Ce marking compliance elite electronic engineering, inc. What are the language requirements for the technical file.
Celab can accomplish all the required tests in order to affix the ce marking related to emc, lvd, red, mdd, machines and many. From any one of our 62 global laboratories, we are. Oct 08, 2012 the ce marking is at least 5 millimetres unless a larger minimum dimension is specified in the relevant directive. Ce marking is a marking on specific products indicating that the manufacturer declares compliance of that product. It is the manufacturers responsibility to carry out the conformity assessment, to set up the technical file, to issue the ec declaration of conformity and to affix ce marking on a product. New directive numbers directive scope 201428eu explosives for civil uses 201429eu simple pressure vessels. Please click the following links to learn more about every cemarking related european union directive, guidelines to directives, frameworks of implementation of directives, and agreements on mutual recognition of conformity assessment between european union and other countries such as usa, japan, canada, australia, new zealand and israel. Best practices for rohs compliance in support of ce marking. Ce marking for machinery directive 9837ec the machinery directive 9837ec is one of the most important european directives for manufacturers of industrial equipment. Ce directives pdf active implantable medical devices directive 90385eec cableway installations directive 20009ec construction products regulation 3052011eu electromagnetic compatibility directive 201430eu environmental design for energyrelated products directive 2009125ec. The machinery directive allows most of the manufacturers to selfcertify their products.
The ce marking is placed onto the product or to its. Products that comply with the ce marking requirements benefit from the following. It simplifies the task of the market surveillance, but also informs you consumer, safety advisors, purchasers, that. If you have changes in product design or characteristics. Ce marking is selfcertification, which is particularly good for small and medium companies. All european ce marking directives oblige the manufacturer to draw up a technical file or in the directives youll also find the term technical documentation.
Learn the basics on technical files with our helpful guidance. One further class of products that are almost machinery are brought into scope of the directive, but they are treated slightly differently to. However overtime the directive is now fairly redundant as all of the directives mentioned have either been superseded or amended to include the ce marking requirement along with the details of affixing the ce mark itself. Ce marking obtaining the certificate, eu requirements. If the product falls under at least one of the ce marking directives, yes. In conclusion the ce marking directive was responsible for the requirements of attaching a ce mark to product. Only in exceptional cases, for example for specific dangerous medical devices, large pressure vessels or construction products, is it necessary to consult a notified body which. Ce marking is mandatory, but only for those products which are covered by the scope of one or more of the new approach directives. Ce marking what it means for ppe what is the meaning of a ce mark. Ce marking is a key indicator of a products compliance with eu legislation and. Affix the ce marking and draw up the eu declaration. With reference to the pressure equipment directive 201468eu article 4 point 3, we hereby declare that above mentioned product has been designed and manufactured in accordance with the sound engineering practice to ensure safe us.
The ce marking that appears on many different products from teddy bears to 30ton hydraulic presses is a important feature of a product and indicates it complies with the detailed essential requirements for that type of products. Service a notified body, a for profit agency, does not provide customer service in. This guide to ce marking is for everyone selling products on the european market who wants to avoid legal pitfalls. If your product is subject to several eu directivesregulations which require a ce marking to be affixed, the accompanying documents must. The definition of machinery in the machinery directive work. Pasadena, california abstract in 2012, the european directive on reduction of hazardous substances was recast. Thirdparty testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturers unverified claim is all thats asked for. The ce marking an acronym for the french conformite europeenne certifies that a product has met eu health, safety, and environmental requirements, which ensure consumer safety. Download the most important ce product guidelines here. Ce marking internal market, industry, entrepreneurship.
The exporter or authorized representative must be able to provide the supporting paperwork to prove ce marking conformity at any time, if requested by the appropriate member state. Only those product categories subject to specific directives that. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them. Despite the fact that the ce mark has been around for more than 15 years, its meaning and importance are often not well. C, other than the equipment and phenomena listed in annex ii. Compile a technical file which contains all these documents to prove compliance. Introduction for lighting products, the ce mark of the european communities signifies the manufacturers or responsible vendors selfdeclaration of conformity with the following directives and regulations. Ce marking can in simple terms be described as a passport or a license to sell allowing free movement within the internal market of the european union. Technical construction file tcf ce ball pressure test result technical construction file tcf is the heart of the ce certification. The following stepbystep plan has been drawn up for the manufacturer. The ce marking directive 9368eec ce marking association. Ce marking on a product is the manufacturers declaration that the product complies with the essential requirements of all the directives regulations that apply to it.
Do make sure that your machine is not listed in annex iv of the directive so you may pursue selfcertification 93% of all machines may be selfcertified. Environmental design for energyrelated products directive. How can wellkang tech consulting help me to obtain ce marking for my product. Machinery directive handbook ce marking for machinery. Ce marking 101 frequently asked questions about ce marking or questions that ought to be asked more frequently by. These pressure vessels require a ce marking above a certain pressurevolume or pressurediameter. To this end, european directives and standards have been and are being developed. Ce marking obtaining the certificate, eu requirements your europe.
Low voltage directive 2 protection against hazards arising from the electrical equipment measures of a technical nature should be prescribed in accordance with point 1, in order to ensure. To affix the ce marking on atex equipment the conformity with emc directive andor pressure equipment directive can also be required. You can view the ec new approach directives guidance from the. The directive references ce marking as per eu decision 7682008, annex ii, module a but that was not clear enough en50581 guidance document was released to clarify technical files requirements related to rohs directive 201165eu 6 rohs. Machinery directive 200642ec your guide to ce marking. Six steps for ce marking pressure equipment ped the pressure equipment directive 201468eu contains the legal obligations for each type of economic operators manufacturer, importer, distributor. Ce marking is only obligatory for products for which eu specifications exist and require the affixing of ce marking. The exporter must maintain a file called a technical file containing the paperwork that proves conformity to the ce marking directive s covering its product. To affix the ce marking on atex equipment the conformity with emc directive andor pressure equipment directive.
Ce marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the european economic area eea. General principles governing the ce marking are set out in regulation ec no 7652008. Machinery within scope of the directive is interpreted very widely and means quoting from article 2a of 200642ec an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application. The ce marking for restriction of hazardous substances is managed by directorategeneral for environment. Celab performs voluntary inspection activities on technical construction files to check their contents. Depending on the product, ce marking may be as simple as formulating a technical file. Ce marking internal market, industry, entrepreneurship and smes.392 1256 1117 912 1011 5 1070 408 746 91 145 181 53 924 894 134 1000 229 95 1312 211 47 1444 1400 942 1178 1059 1060 1032 1063 1067 809 331 771 869 63 1491 475